QA Gdp

il y a 3 heures

Brussels, Belgique Jefferson Wells Temps plein

Location:

- **BRUXELLES**- Type:

- **Contracting**:

- **#17352**

**QA GDP**:
Walloon Brabant - Contracting

**#QA #GDP #QMS #incident #SOP #oversight #quality #qualitymanagement #pharma #audits**

Our client is currently looking for a **QA GDP** to reinforce its teams. Our client is a pharmaceutical company well-known for its medicines.

**What are your responsibilities?**:
As a **QA GDP**, you will be in charge of different tasks:
I. Quality Management System (QMS)
- Contribute in the maintenance of an effective and sustainable QMS.
- Ensure timely implementation of all applicable global Standard Operating Procedures (GSOP) and local SOPs within the PCO.
- Ensure all relevant PCO colleagues are appropriately trained in applicable procedures.
- Supervise all processes related to GDP (drug supply, stock management, stock availability, relabeling/repackaging, customer management, (logistics) complaint handling, transport of products, including temperature monitoring, product disposal ) and GMP (relabeling/repackaging and pharmaceutical operations).

II. Incident Management
- Investigate, together with appropriate local/global functions, incidents against Product Quality and/or Compliance requirements that occur within the responsibility of the PCO organization. Agree and track preventive/corrective actions. Local investigations may relate to product damage, artwork and labeling errors, counterfeit, temperature excursion during transport or issues with contract manufacturers or logistics service providers, etc.

III. Local Product Dispositioning
- Local administrative release verification in compliance with the applicable local regulations and procedures prior to distribution/sale within the market.
- Evaluate which returns can be taken into consideration for return to saleable stock, supervise and support local actions, in cooperation with logistics and distribution center.

IV. Product Complaint Handling
- Support the process of compliant handling of product quality complaints.

V. Oversight of local Repackaging and Relabeling Operations
- Review documentation related to the repackaging/relabeling operation and follow-up corrections if required.
- Obtain regulatory approval of the repackaging/relabeling activity, if required under the local regulations.
- Inform the releasing site of the repackaging/relabeling activity.
- Release the repackaged/relabeled product prior to distribution/sale within country.

VI. Development and Maintenance of Consistent Quality Culture
- Provide ongoing education on Quality to relevant PCO functional groups, to increase awareness and understanding of requirements and enhance the Quality Culture.

VII. Local Vendor Quality Management
- Oversee quality operations at contractors, which includes but is not limited to:

- Contractor Assessment and Approval: ensure all GMP/GDP contractors have been formally assessed and approved.
- Deviation Management: evaluate the impact of all significant deviations affecting safety, identity, strength, purity & quality (SISPQ), generated at the contractor and agree upon corrective actions. If necessary, initiate the “Notification to Management” process.
- Quality System Support: assess Contractor’s quality systems, review quality performance and agree upon action plans to ensure continuous improvement. Include quality reviews during Business Review Meeting (BRM).
- Issue and review Metrics: Periodically assess the overall quality risk associated to the contractor. Act on adverse trends in order to improve contractor quality and compliance performance.

VIII. Site Self Audits
- Ensure the Site Self Audits programs for the PCO are conducted in an appropriate way, clearly documented and completed in time.

IX. Quality Management Review
- Review the adequacy, suitability and effectiveness of the QMS, by monitoring quality performance metrics and identifying actions to improve operations under local Quality responsibility.

**Who are you?**:
You hold a degree in sciences. You have a relevant experience in a Quality Operations, Manufacturing or Regulatory role within the pharmaceutical industry. An experience with GDP standards is an asset. You speak fluently French and English. You are a problem solver, structured and stress resistant.

**What can you expect?**:
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.

You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Marie Defruit,

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